NCT02567890

Brief Summary

Women in general and young girls in particular are constantly exposed to unhealthy body and appearance ideals through media that contribute to body dissatisfaction and unhealthy behaviors such as rigid dieting, which in interaction with genes and other factors increase the risk of developing eating disorders such as anorexia nervosa and bulimia nervosa. The investigators aim is to investigate the extent to which an interactive prevention program, delivered through Internet, called the Swedish Body Project (sBody Project) can decrease the emergence of eating disorders among young females. The sBody Project is based on a "Dissonance-Based Intervention: (DBI)" that has shown very promising results. The adaptations and changes in the format of delivery accomplished in this study might help to disseminate the program on a broad basis, and consequently affect the health of young females on a much larger scale the ever before.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
443

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

September 30, 2015

Last Update Submit

August 1, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in the occurrence of Eating disorder diagnosis

    Diagnostic interview to establish the diagnoses of eating disorders

    6 12, 18 and 24 months after the completed intervention that lasts 4 weeks

Secondary Outcomes (8)

  • Composite EDE score

    Pre-assessment, and 6, 12, and 24 months post intervention

  • Self-reported ED symptoms based on the Eating Disorder Diagnostic Scale

    Pre-assessment, and 6, 12, 18, and 24 months post intervention

  • Positive and Negative Affect

    Pre-assessment, and 6, 12, 18, and 24 months post intervention

  • Restraint

    Pre-assessment, and 6, 12, 18, and 24 months post intervention

  • Functional impairment due to eating disorder problems

    Pre-assessment, and 6, 12, 18, and 24 months post intervention

  • +3 more secondary outcomes

Study Arms (3)

Internet-based DBI

EXPERIMENTAL

Internet-based DBI, which consists of four interactive occasions, some homework assignments, and monitoring

Behavioral: Internet-based DBI

Expressive writing

PLACEBO COMPARATOR

Expressive Writing (placebo/attention control) where participants write texts. This is the active control condition.

Behavioral: Expressive writing

Waiting list

NO INTERVENTION

A wait-list control condition.Those in the wait-list condition will not receive any treatment until they have done the 6-month follow-up assessment.

Interventions

Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.

Also known as: sBody Project
Internet-based DBI

Participants will be asked to reflect upon issues related to body image.

Expressive writing

Eligibility Criteria

Age15 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Must have self-reported body dissatisfaction that is an established risk factor for the development of eating disorders.

You may not qualify if:

  • Those who meet the diagnostic criteria for any eating disorder diagnosis, body dysmorphic disorder, or other serious conditions (e.g., bipolar disorders, schizophrenia) that require psychiatric care will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Solna, 17177, Sweden

Location

Related Publications (12)

  • Stice E, Shaw H. Eating disorder prevention programs: a meta-analytic review. Psychol Bull. 2004 Mar;130(2):206-27. doi: 10.1037/0033-2909.130.2.206.

    PMID: 14979770BACKGROUND
  • Stice E, Rohde P, Durant S, Shaw H. A preliminary trial of a prototype Internet dissonance-based eating disorder prevention program for young women with body image concerns. J Consult Clin Psychol. 2012 Oct;80(5):907-16. doi: 10.1037/a0028016. Epub 2012 Apr 16.

    PMID: 22506791BACKGROUND
  • Stice E, Schupak-Neuberg E, Shaw HE, Stein RI. Relation of media exposure to eating disorder symptomatology: an examination of mediating mechanisms. J Abnorm Psychol. 1994 Nov;103(4):836-40. doi: 10.1037//0021-843x.103.4.836.

    PMID: 7822589BACKGROUND
  • Stice E, Shaw H, Becker CB, Rohde P. Dissonance-based Interventions for the prevention of eating disorders: using persuasion principles to promote health. Prev Sci. 2008 Jun;9(2):114-28. doi: 10.1007/s11121-008-0093-x. Epub 2008 May 28.

    PMID: 18506621BACKGROUND
  • Stice E, Shaw H, Marti CN. A meta-analytic review of eating disorder prevention programs: encouraging findings. Annu Rev Clin Psychol. 2007;3:207-31. doi: 10.1146/annurev.clinpsy.3.022806.091447.

    PMID: 17716054BACKGROUND
  • Stice E, Trost A, Chase A. Healthy weight control and dissonance-based eating disorder prevention programs: results from a controlled trial. Int J Eat Disord. 2003 Jan;33(1):10-21. doi: 10.1002/eat.10109.

    PMID: 12474195BACKGROUND
  • White JH. Women and eating disorders, Part I: Significance and sociocultural risk factors. Health Care Women Int. 1992 Oct-Dec;13(4):351-62. doi: 10.1080/07399339209516013.

    PMID: 1478897BACKGROUND
  • Welch E, Miller JL, Ghaderi A, Vaillancourt T. Does perfectionism mediate or moderate the relation between body dissatisfaction and disordered eating attitudes and behaviors? Eat Behav. 2009 Aug;10(3):168-75. doi: 10.1016/j.eatbeh.2009.05.002. Epub 2009 May 21.

    PMID: 19665100BACKGROUND
  • Welch E, Lagerstrom M, Ghaderi A. Body shape questionnaire: psychometric properties of the short version (BSQ-8C) and norms from the general Swedish population. Body Image. 2012 Sep;9(4):547-50. doi: 10.1016/j.bodyim.2012.04.009. Epub 2012 Jun 19.

    PMID: 22721875BACKGROUND
  • Welch E, Birgegard A, Parling T, Ghaderi A. Eating disorder examination questionnaire and clinical impairment assessment questionnaire: general population and clinical norms for young adult women in Sweden. Behav Res Ther. 2011 Feb;49(2):85-91. doi: 10.1016/j.brat.2010.10.010. Epub 2010 Nov 2.

    PMID: 21185552BACKGROUND
  • Treasure J, Macare C, Mentxaka IO, Harrison A. The use of a vodcast to support eating and reduce anxiety in people with eating disorder: A case series. Eur Eat Disord Rev. 2010 Nov-Dec;18(6):515-21. doi: 10.1002/erv.1034.

    PMID: 20669153BACKGROUND
  • Ghaderi A, Stice E, Andersson G, Eno Persson J, Allzen E. A randomized controlled trial of the effectiveness of virtually delivered Body Project (vBP) groups to prevent eating disorders. J Consult Clin Psychol. 2020 Jul;88(7):643-656. doi: 10.1037/ccp0000506.

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Ata Ghaderi, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 5, 2015

Study Start

September 1, 2015

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations